The data that has
been assembled, taken together with the deficiency in knowledge, about
the incorporation of Bacillus thuringiensis (Bt) into plants as a means
of pest control supports a moratorium on its continued registration as
plant pesticides under the standards of the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA). EPA has not received data that the use of
these genetically altered plants will not cause unreasonable adverse effects
on the environment," defined as "any unreasonable risk to man
or the environment, taking into account the economic, social, and environmental
costs and benefits of the use of any pesticide . . . ." In fact,
the experience with the use of genetically altered Bt crops raises serious
safety concerns for agriculture in at least three key areas: gene flow
to wild relatives; risks of insect resistance; and risks to non-target
species. Until these questions are, EPA is allowing, contrary to law,
the release of a technology that may have serious ramifications on agricultural
production down the road.

EPA Has Not Fully
Evaluated Insect Resistance

EPA review process
and its experience with insect resistance is flawed. Historically, the
agency has allowed the release of synthetic toxic materials into the environment
without a full assessment as to the efficacy of these products over the
long term. The result has been the release of hazardous materials, including
arsenic, organochlorine, organophosphate, carbamate, synthetic pyrethroid
and other chemical families, that over time have severely lost efficacy,
while leaving a trail of adverse toxic effects. Through a flawed conditional
registration process, EPA has embarked on the same course, this time playing
with DNA material and life forms that may well get out of control. As
many in the scientific community have said, very slow processes may be
taking place now that are inherently very unpredictable and dangerous.
The molecular facts are this: biotechnology is an unpredictable industrial
practice, as Barry Commoner, Ph.D. has said. Because of this unpredictability,
EPA should not be issuing or extending conditional registrations or granting
full registrations without full information and complete assurances about
short- and long-term impacts.

EPA Has Not Fully
Evaluated the Cost of Declining Bt Efficacy

Besides the direct
impact of Bt plant pesticides, EPA must calculate the impact on agriculture
and the growing organic agriculture market if, under one plausible scenario,
target and non-target insects become resistant to the Bt toxin. In other
words, what economic impact will the loss of this pesticide have on the
now nearly $10 billion industry? In addition, what impact will the loss
of this pesticide have on the economic viability of those agriculturalists
practicing integrated pest management, a rising number in the agricultural
community? Unless EPA can prove that Bt plant pesticides will have no
adverse impact on the efficacy of Bt, the economic analysis performed
must evaluate the economic cost of lack of efficacy.

Non-Target Impact
Cannot be Dismissed as Inconsequential

Bt incorporated plants
harm butterflies, such as monarchs and the endangered Karner Blue. The
agency does not have sufficient data to dismiss scientific findings that
show migrating monarchs exposed to Bt corn pollen at risk. The agency,
similarly, does not have sufficient data to show that pollinators are
not put at risk. In order to make a finding of reasonable risk under FIFRA,
the agency must be proactive and definitive in looking at the short- and
long-term impacts in this area.

Lack of Enforcement
Capability

EPA relies on a pesticide
enforcement system that is broken. Compliance with pesticide label restrictions
is very low and the agency knows it. The agency does not have an enforcement
plan that will ensure compliance with mitigation measures, but simply
engages in writing restrictive language for which it has no to limited
capability to enforce.

Human Health Effects
Not Adequately Considered

EPA has failed the
public in not considering the widespread allergenic effects of Bt plant
pesticides. Evidence suggests that protein manipulation in plants can
cause adverse reactions in humans that eat them. This area needs further
study and raises some of the most serious implications for a technology
that has not been fully evaluated prior to its widespread introduction
into the marketplace.

In a report released
on December 7, 2000, EPA's Office of Pesticide Programs Scientific Advisory
Panel (SAP) announced there is a "medium likelihood" that the
StarLink protein found in Aventis CropScience's genetically modified corn,
which illegally entered the US food supply, is a potential food allergen.
The biotech corn, which has not been approved for human consumption or
export, has been showing up in taco shells and other processed foods,
both in the U.S. and around the globe. In an effort to soften the blow
of a costly recall, Aventis asked EPA to temporarily approve its StarLink
corn, which has been genetically modified to produce the pesticide Bt,
for human consumption. Beyond Pesticides argues that humans should not
be used as guinea pigs, and Aventis should not be rewarded for violating
the law with an after-the-fact approval of a potentially dangerous product.
Japan, also angry that the StarLink corn has entered their food supply,
asked the U.S. embassy to take the appropriate measure to correct the
situation.

In an attempt to evaluate
Aventis's request, EPA asked the SAP, comprised of experts, to provide
an independent scientific assessment on the potential allergenicity, sensitization
and possible exposure to StarLink corn. In a one-day meeting held in Washington,
DC on November 28, 2000 the SAP probed questions regarding the allergenicity
of StarLink corn to consumers, and the degree to which its proliferation
in the human food supply could be a health risk to consumers. The panel
heard presentations by EPA, incidence reports filed to the agency by consumers
who claimed they had allergic reactions after eating StarLink, and testimony
from Aventis, along with other industry and public interest groups. Both
the SAP's recommendations and the public comments that were received by
EPA will be used to guide the agency during the scientific evaluation
of the StarLink corn.

Keith Finger, a Florida
optometrist, had severe allergic reactions to StarLink corn, a genetically
engineered yellow corn variety. Keith Finger is only one of seventeen
people who reported having allergic reactions after eating StarLink corn
products. The Center for Disease Prevention and Control reported that
these seventeen people had tested positive for sensitivity of the specific
protein found only in the StarLink corn. The Washington Post explains
Finger's reactions to the corn, "Keith Finger showed the panel pictures
of welts and rashes he says he suffered Sunday after he ate a mixture
of StarLink corn and water."

This StarLink corn
contains a protein, Cry9C, which breaks down slowly in the digestive tract.
Last month, The Food and Drug Administration found this protein in Kash
n' Karry White Corn Tortilla Chips. The Washington Post reports, "StarLink
corn was never approved for human consumption because of questions about
whether it was an allergen." After discovery of these products last
fall, the nation announced a recall of StarLink corn products.

Scientists are now
debating whether or not this corn containing Cry9C should be allowed on
the market at a maximum level of 20 parts per billion, the equivalent
of one StarLink kernel in every 800 kernels of corn2. Currently, the corn
is withdrawn from the market. The Washington Post reports, "The Agriculture
Department reported Tuesday that it had accounted for all but 720,000
of the 128 bushels of StarLink corn. Another 4.9 million bushels may have
been mixed with grain that went to food processors". Aventis CropScience,
the crop's developer, is pushing to have the Environmental Protection
Agency allow a small amount of this variety of corn in the food supply
to prevent further hassle and increased recalls.

The Washington Post
reports, "The presence of StarLink in a white corn product illustrates
how difficult it is to keep genetically modified crops from spreading".
Although white corn is not grown or shipped with yellow corn, there are
many times when the two varieties are accidentally mixed. The Industry
told the Washington Post, "The mixing could happen at processing
plants, during transportation and through cross-pollination in fields."

Cross Contamination
Has Eluded EPA for Decades and Is Completely Unacceptable with Genetically
Modified Organisms

The Cry9C protein
found in the genetically engineered StarLink corn, manufactured by Aventis
CropScience, has been detected in another variety of corn, raising serious
questions about how it got there and how much additional corn could be
contaminated. The contamination of StarLink corn, which has been approved
by EPA only for animal feed based on studies showing that humans cannot
properly digest it, sparked the recall of thousands of taco shells and
other products containing the corn in October.

According to a statement
by the manufacturer, "Aventis CropScience performed the tests after
several farmers stated that corn with no known connection to StarLink
was testing positive for Cry9C. Aventis CropScience does not know how
Cry9C protein came to be present in a variety other than StarLink brand
seeds."

We find this lack
of knowledge very disturbing, and a strong argument for tighter controls
on genetically modified organisms (GMOs). Because the protein found in
the genetically modified StarLink corn causes the plant to produce the
pesticide Bt within the cells of the plant, people would be consuming
for greater quantities than ever before, exposing themselves to toxins
and potential food allergies.

Farmers Are Adversely
Impacted by the Uncontrolled Nature of the Technology

Farmers in Cedar Rapids,
Iowa have filed a class action lawsuit on behalf of a nationwide group
of farmers against Aventis for the contamination of their corn crop with
the genetically modified corn. The farmers are seeking damages and calling
on the company to decontaminate their farms.

According to Farm
Progress, the lawsuit seeks nationwide class action status on behalf of
all farmers who cultivated and harvested non-StarLink corn in the United
States for commercial purposes from 1998 to the present. The lawsuit alleges
that there has been widespread contamination of the United States corn
crop by the StarLink product, both through cross-pollination of corn crops
in farmers' fields as well as in grain elevators and other corn storage
facilities. It also alleges that this contamination was directly caused
by Aventis' "intentional, reckless, and/or negligent" conduct.
This resulted in substantial damages to members of the class by virtue
of, among other things, losses in export and domestic markets for United
States corn and the consequent decline in sales prices for United States
farmers' corn in these markets. EPA has not calculated this and future
similar problems into its benefits analysis.

These comments provides
the basis for EPA to put the brakes on Bt plant pesticides until such
time as the serious questions that have been raised are answered. This
technology should not be unleashed on the world given what is now scientifically
known and under the standards of United States law.